Juniperus Oxycedrus and Cupressus Arizonica Allergen Extracts Standardisation.

NCT05533385 | Completed

• 2 other identifiers: T521-STD-0442020-005389-32
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study is to determine the biological activity of Juniperus oxycedrus and Cupressus arizonica. allergen extracts in histamine equivalent prick (HEP) units, in order to be used as in-house reference preparation (IHRP).

Conditions

Allergy Pollen; Allergic Reaction; Allergic Skin Reaction

Keywords

Allergy

Outcome Measures

Primary Outcomes (2)

• Size of the induced papule on the skin

  Size of the induced papule on the skin when applying each of the concentrations of the allergenic extracts and the positive (histamine) and negative controls, using the prick test.

  15 minutes

• Adverse reactions

  Mild secondary reactions such as pruritus, erythema, local edema, etc. There is a risk, infrequent and exceptional, of systemic reactions, sometimes severe (urticaria, asthma, anaphylactic shock, etc.).

  30 minutes

Study Arms (1)

Extract J. oxycedrus + extract C. arizonica + positive control + negative control

EXPERIMENTAL

There is only one treatment arm. In each subject, one drop of each of the 3 concentrations of each allergenic extract (2 extracts) will be applied in addition to the positive control (histamine 10 mg/mL) and the negative control, with prick test. Juniperus oxycedrus: 300, 60 and 12 µg/mL Cupressus arizonica: 100, 20 and 4 µg/mL

Other: Allergenic extract

Interventions

Allergenic extract OTHER

In each subject a drop of each of the 3 concentrations of both allergenic extracts will be applied in addition to the positive control (histamine) and the negative control. The application will be made in duplicate on the anterior face of the subject's arm. The distance between each application should be approximately 4 cm.

Also known as: Allergenic Juniperus oxycedrus and Cupressus arizonica extract

Extract J. oxycedrus + extract C. arizonica + positive control + negative control

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Subjects must live in a geographical area where allergic problems caused by Juniperus oxycedrus and Cupressus arizonica are relevant.
• Positive clinical history of inhalant allergy (rhinitis and/or rhinoconjunctivitis and/or asthma) to asthma) to Juniperus oxycedrus and Cupressus arizonica.
• A positive prick-test (mean papule diameter ≥ 3 mm) with an extract of the same allergen and/or presence of specific IgE against that allergen.
• The mean papule area obtained with Histamine dichlorhydrate at 10 mg/mL should be ≥ 7 mm2.
• Age: Between 18 and 64 years old.
• Both sexes.
• Subjects must be able to give informed consent.
• Women of childbearing age (since menarche) must present a negative urine pregnancy test at the time of enrollment in the trial.

You may not qualify if:

• Subjects should not be excluded in terms of low or high sensitivity to Juniperus oxycedrus and Cupressus arizonica.
• Subjects outside the age range.
• Subjects who have previously received immunotherapy in the last 5 years for the treatment of asthma or rhinoconjunctivitis for the treatment of asthma or allergic rhinoconjunctivitis induced by allergens that may interfere with Juniperus oxycedrus and Cupressus arizonica extracts.
• Subjects with significant symptoms of rhinoconjunctivitis and/or bronchial asthma in which the suspension of the systemic antihistamine treatment is contraindicated.
• Subjects who have previously presented a severe secondary reaction during the performance of diagnostic skin tests by prick test.
• Subjects under treatment with ß-blockers.
• Subjects clinically unstable (acute asthma, febrile, etc.).
• Subjects with active urticaria lesions, severe active dermographism, severe atopic dermatitis, sunburn, eczema, psoriasis lesions in the area where the prick test is performed (risk of false positives).
• Subjects with active viral infection by herpes simplex or herpes varicella zoster in the area where the prick test is performed.
• Subjects with any pathology in which the administration of adrenaline is contraindicated (hyperthyroidism, HTA, cardiopathy, etc.).
• States of the subject in which he/she cannot offer cooperation and severe psychiatric disorders.
• Pregnant women or women at risk of pregnancy and lactating women.

Sponsors & Collaborators

• Inmunotek S.L.: lead

Study Sites (1)

Clínica Subiza, centro de asma y alergia

Madrid, Madrid, Spain

Location

MeSH Terms

Conditions

Rhinitis, Allergic, Seasonal; Hypersensitivity

Interventions

grass pollen extract, alum-adsorbed

Condition Hierarchy (Ancestors)

Rhinitis, Allergic; Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Immune System Diseases

Study Officials

• Javier Subiza, DM

  Clinica Subiza, centro de asma y alergia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Phase II, open-label, non-randomized trial, with no control group of subjects.

Study Record Dates

• First Submitted: September 5, 2022
• First Posted: September 9, 2022
• Study Start: October 10, 2023
• Primary Completion: January 22, 2024
• Study Completion: January 22, 2024
• Last Updated: September 19, 2024

Record last verified: 2024-09

Locations

ES (1)